Sulfacetamide Na 10% Oph Soln 15ml
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Sulfonamide Antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sulfacetamide eye drops are an antibiotic medication used to treat bacterial infections of the eye, such as conjunctivitis (pink eye). They work by stopping the growth of bacteria.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Avoid touching the container tip to your eye, lid, or other skin, as this can introduce bacteria into the medication, potentially leading to severe eye problems or vision loss.
4. Unless advised by your doctor, avoid wearing contact lenses during treatment.
5. To administer the medication, tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Important Safety Precautions
- Do not use the medication if the solution changes color, as this may indicate contamination or degradation.
Storage and Disposal
- Store the medication at room temperature, avoiding freezing.
- Protect the medication from light to preserve its effectiveness.
- Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Avoid touching the container tip to your eye, lid, or other skin, as this can introduce bacteria into the medication, potentially leading to severe eye problems or vision loss.
4. Unless advised by your doctor, avoid wearing contact lenses during treatment.
5. To administer the medication, tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Important Safety Precautions
- Do not use the medication if the solution changes color, as this may indicate contamination or degradation.
Storage and Disposal
- Store the medication at room temperature, avoiding freezing.
- Protect the medication from light to preserve its effectiveness.
- Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them (unless advised otherwise by your doctor).
- Do not share eye drops with others.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Avoid rubbing your eyes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops into the conjunctival sac every 2-4 hours initially, then less frequently as infection responds.
Condition-Specific Dosing:
severeInfections:
1-2 drops every 1-2 hours initially.
Pediatric Dosing
Neonatal:
Not established (use with caution, risk of kernicterus in premature infants due to systemic absorption, though minimal with ophthalmic use).
Infant:
1-2 drops into the conjunctival sac every 2-4 hours initially, then less frequently as infection responds.
Child:
1-2 drops into the conjunctival sac every 2-4 hours initially, then less frequently as infection responds.
Adolescent:
1-2 drops into the conjunctival sac every 2-4 hours initially, then less frequently as infection responds.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations for ophthalmic use (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that inhibits bacterial growth by interfering with the synthesis of folic acid (para-aminobenzoic acid antagonism), which is essential for bacterial cell growth. It is bacteriostatic.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration.
Tmax:
Not applicable for ophthalmic use (minimal systemic absorption).
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not applicable for ophthalmic use (minimal systemic absorption).
ProteinBinding:
Not applicable for ophthalmic use (minimal systemic absorption).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for ophthalmic use (minimal systemic absorption).
Clearance:
Not applicable for ophthalmic use (minimal systemic absorption).
ExcretionRoute:
Not applicable for ophthalmic use (minimal systemic absorption).
Unchanged:
Not applicable for ophthalmic use (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Within hours to days for clinical improvement.
PeakEffect:
Within days of consistent use.
DurationOfAction:
Dependent on dosing frequency and infection severity.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye discharge
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
+ If you experience any of the following, call your doctor right away:
- Rash
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
- Fever, chills, or sore throat
- Cough that is new or worsening
- Feeling very tired or weak
- Any bruising or bleeding
- Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burning or stinging
Eye irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye discharge
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
+ If you experience any of the following, call your doctor right away:
- Rash
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
- Fever, chills, or sore throat
- Cough that is new or worsening
- Feeling very tired or weak
- Any bruising or bleeding
- Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burning or stinging
Eye irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening eye redness, pain, or discharge after a few days of treatment.
- Severe burning, stinging, or itching after applying the drops.
- Swelling of the eyelids or face.
- Rash or hives anywhere on the body.
- Any new or unusual eye symptoms.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a known sulfa allergy, as this may affect your ability to take this medication safely.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a known sulfa allergy, as this may affect your ability to take this medication safely.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision to ensure your safety. Do not exceed the prescribed duration of use, as this may increase the risk of a secondary infection. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidental ingestion occurs, or if severe local irritation develops, rinse eye with water and contact a poison control center or seek medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Contraindicated Interactions
- Silver preparations (e.g., silver nitrate): Incompatible, may precipitate.
Moderate Interactions
- Other sulfonamides, sulfonylureas, thiazide diuretics, carbonic anhydrase inhibitors: Theoretical cross-sensitivity/allergic reactions due to sulfonamide moiety, though rare with ophthalmic use.
Monitoring
Baseline Monitoring
Ophthalmic examination (visual acuity, conjunctival injection, discharge)
Rationale: To assess the severity and nature of the eye infection.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in redness, discharge, discomfort)
Frequency: Daily
Target: Improvement of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 3-4 days, or signs of irritation/allergic reaction.
Signs of local irritation or hypersensitivity (itching, swelling, burning)
Frequency: Daily
Target: Absence of new or worsening irritation
Action Threshold: Development of severe or persistent irritation.
Symptom Monitoring
- Eye redness
- Eye discharge (purulent or watery)
- Eye pain or discomfort
- Itching or burning sensation in the eye
- Swelling of eyelids or conjunctiva
- Blurred vision (if related to infection)
Special Patient Groups
Pregnancy
Use with caution. While systemic absorption from ophthalmic use is minimal, sulfacetamide is a sulfonamide. Systemic sulfonamides are Category C, with potential for kernicterus in neonates if used near term. Ophthalmic use is generally considered low risk, but benefits should outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Potential theoretical risk of kernicterus in premature infants if significant systemic absorption occurs, though highly unlikely with ophthalmic use.
Lactation
Considered L3 (Moderately Safe). Minimal systemic absorption is expected, making infant exposure low. Monitor infant for diarrhea or rash. Alternative agents with even lower systemic absorption may be preferred if available.
Infant Risk:
Low (due to minimal maternal systemic absorption and excretion into breast milk).
Pediatric Use
Generally safe for use in children. However, caution is advised in neonates, especially premature infants, due to theoretical risk of kernicterus with systemic sulfonamide exposure, though this is extremely rare with ophthalmic use.
Geriatric Use
No specific dosage adjustments are typically required. Use with caution in patients with known sulfonamide hypersensitivity.
Clinical Information
Clinical Pearls
- Sulfacetamide ophthalmic solution is effective against many common bacterial eye pathogens, but resistance can develop.
- Incompatibility with silver preparations (e.g., silver nitrate) is important; avoid concomitant use.
- Patients should be advised to avoid wearing contact lenses during treatment for bacterial conjunctivitis.
- Store at room temperature, away from light. Do not freeze.
- Discontinue use if signs of hypersensitivity or severe irritation occur.
- The solution may sting slightly upon instillation, which is usually transient.
Alternative Therapies
- Tobramycin ophthalmic solution/ointment
- Moxifloxacin ophthalmic solution
- Gatifloxacin ophthalmic solution
- Erythromycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic solution
Cost & Coverage
Average Cost:
$10 - $30 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.